DBV Technologies Expands and Strengthens Leadership Team
January 03 2019 - 1:31AM
Montrouge, France, January 3, 2019 |
DBV Technologies Expands and Strengthens
Leadership Team
Key medical, manufacturing and regulatory
leadership changes announced ahead of anticipated Viaskin Peanut
BLA resubmission
Dr. Hugh Sampson to assume role of interim Chief
Medical Officer
Company engages manufacturing and operations
industry leader Julie O'Neill
DBV Technologies (Euronext: DBV - ISIN:
FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today announced the following changes to
its leadership team as the Company strengthens its organizational
competencies in the development of the Viaskin platform:
- DBV's Chief Scientific Officer (CSO), Dr. Hugh Sampson, will
also assume the role of interim Chief Medical Officer (CMO)
effective today. Dr. Sampson succeeds Dr. Lucia Septien-Velez, who
has decided to leave to pursue other opportunities. As CSO and
interim CMO, Dr. Sampson will lead both the scientific and medical
teams at the Company and will report to Daniel Tassé, Chief
Executive Officer of DBV Technologies. Dr. Sampson is an
accomplished leader and physician, and his research and scientific
advancements have had a significant influence in the field of food
allergies and immunology over the last 40 years.
- Following recent interactions with the U.S. Food and Drug
Administration (FDA), global manufacturing industry leader, Julie
O'Neill, has been engaged effective immediately to direct all
product development, manufacturing, supply chain, quality
assurance, and end-to-end process optimization at the Company. She
brings over 30 years of experience in global manufacturing to DBV,
where she will directly advise Daniel Tassé. Julie, who was
appointed to DBV's Board of Directors in 2017, will continue
serving as a director, while overseeing the anticipated
resubmission of the Viaskin Peanut Biologics License Application
(BLA) in children four to 11 years of age. Most recently, Julie was
Executive Vice President, Global Operations for Alexion
Pharmaceuticals Inc.
- As part of these operational changes announced today, Alan
Kerr, Senior Vice President, Head of Global Regulatory Affairs of
DBV Technologies, will now report to the Company's CEO, Daniel
Tassé, effective immediately.
Daniel Tassé, CEO, stated: "These
operational changes mark an important transition for DBV as we
continue to evolve from late-stage research and development into a
potentially commercial-stage company. We believe Hugh and Julie
bring a critical set of skills that will strengthen our ability to
deliver innovative Viaskin product candidates to patients and
families worldwide. They will work closely with our regulatory team
to potentially bring Viaskin Peanut to children suffering from
peanut allergy as quickly as possible." Daniel added, "Hugh
is one of the leading voices in the field of food allergies and
immunology, and we are thrilled to have him at the helm of our
scientific and medical strategy for the Viaskin platform. And we
are thrilled to welcome Julie, who is an accomplished leader with a
proven record of success in manufacturing excellence for over three
decades, overseeing several FDA biological approvals. Hugh and
Julie's expertise, coupled with their unwavering commitment to
serving patients, make them right leaders to drive our anticipated
upcoming resubmission of the BLA for Viaskin Peanut."
Dr. Hugh SampsonEffective today, Dr. Sampson
will lead both scientific and medical efforts at the Company. In
collaboration with the Company's regulatory experts, Dr. Sampson
will also support regulatory submissions for Viaskin Peanut, while
continuing to drive scientific innovation of the Company's
proprietary technology platform, Viaskin. DBV has launched a search
for a permanent CMO based in the United States.
"We are very thankful for Lucia's commitment over
the years, and I am excited to lead DBV through this exciting phase
as we prepare to resubmit our BLA for Viaskin Peanut," said Dr.
Hugh Sampson. "From the moment I joined DBV as CSO, I have been
excited about our platform's potential to offer novel product
candidates that could have a meaningful impact across the lives of
millions of patients. I am looking forward to working with a team
of passionate scientific and medical experts worldwide, who are
deeply committed to helping patients with unmet medical needs."
Dr. Sampson was appointed CSO of DBV Technologies
in June 2015 and is a member of the Company's Executive Committee
and Scientific Advisory Board. He is also the Kurt Hirschhorn
Professor of Pediatrics at the Icahn School of Medicine at Mount
Sinai and Director Emeritus of the Jaffe Food Allergy Institute.
Dr. Sampson continues to direct NIH-funded translational research
activities and is past chair of the Section on Allergy &
Immunology of the American Academy of Pediatrics and the
past-president of the American Academy of Allergy, Asthma and
Immunology (AAAAI). He has published over 300 peer-reviewed
articles in the field of food allergies and immunology. Dr. Sampson
earned his medical degree from the State University of New York at
Buffalo School of Medicine and completed his fellowship in allergy
and immunology at Duke University.
Julie O'NeillJulie brings over 30 years of
experience to DBV, where she will direct all global manufacturing
operations. From 2014 to 2018, Julie was Executive Vice President,
Global Operations for Alexion Pharmaceuticals Inc, responsible for
global process development and manufacturing, as well as for the
Company's supply chain, quality and real estate operations. Before
joining Alexion, she was Vice President of Operations and General
Manager for Ireland at Gilead Sciences, Inc. Earlier in her career,
Julie held leadership positions in operations, manufacturing and
quality functions within the pharmaceutical industry.
"The Viaskin platform is a fascinating technology
with a novel approach to process innovation, and I am excited to be
part of the pioneering team behind its advancement for
biopharmaceutical production," said Julie O'Neill. "My time
on DBV's Board has reinforced my excitement about Viaskin Peanut as
a potential treatment for peanut-allergic patients, and I am
looking forward to leading the team through the resubmission of our
BLA package to the FDA as quickly as possible."
About DBV Technologies
DBV Technologies is developing Viaskin®, a
proprietary technology platform with broad potential applications
in immunotherapy. Viaskin is based on epicutaneous immunotherapy,
or EPIT®, DBV's method of delivering biologically active compounds
to the immune system through intact skin. With this new class of
self-administered and non-invasive product candidates, the Company
is dedicated to safely transforming the care of food allergic
patients, for whom there are no approved treatments. DBV's food
allergies programs include ongoing clinical trials of Viaskin
Peanut and Viaskin Milk, and Montrouge, France, October 22, 2018
preclinical development of Viaskin Egg. DBV is also pursuing a
human proof-of-concept clinical study of Viaskin Milk for the
treatment of Eosinophilic Esophagitis, and exploring potential
applications of its platform in vaccines and other immune diseases.
DBV Technologies has global headquarters in Montrouge, France and
New York, NY. The Company's ordinary shares are traded on segment A
of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of
the SBF120 index, and the Company's ADSs (each representing
one-half of one ordinary share) are traded on the Nasdaq Global
Select Market (Ticker: DBVT).
Forward Looking Statements
This press release may contain forward-looking
statements and estimates, including statements regarding the
potential of the Company's Viaskin platform, Company's regulatory
plans regarding Viaskin Peanut and the anticipated benefits to be
derived from the management changes announced herein. These
forward-looking statements and estimates are not promises or
guarantees and involve substantial risks and uncertainties. At this
stage, the products of the Company have not been authorized for
sale in any country. Among the factors that could cause actual
results to differ materially from those described or projected
herein include uncertainties associated generally with related
regulatory reviews and approvals and clinical trials, as well as
those associated with attracting and retaining key personnel. A
further list and description of these risks, uncertainties and
other risks can be found in the Company's regulatory filings with
the French Autorité des Marchés Financiers, the Company's
Securities and Exchange Commission filings and reports, including
in the Company's Annual Report on Form 20-F for the year ended
December 31, 2017 and future filings and reports by the Company.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements and estimates, which
speak only as of the date hereof. Other than as required by
applicable law, DBV Technologies undertakes no obligation to update
or revise the information contained in this Press Release.
DBV Investor Relations Contact Sara Blum
ShermanSenior Director, Investor Relations &
Strategy+1 212-271-0740sara.sherman@dbv-technologies.com
DBV Media Contact Joe BeckerVP, Global
Corporate Communications
+1 646-650-3912joseph.becker@dbv-technologies.com
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